Lab automation in Big Pharma status and look forward. Lab automation 2016 Geert Verdonk Oss April 2016

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1 Lab automation in Big Pharma status and look forward Lab automation 2016 Geert Verdonk Oss April 2016

2 Introduction Geert Verdonk Global Center of Expertise in Microbiology Support production and labs in case of trouble New technology development Act as microbiological knowledge center for Merck

3 Global CoE with Regional Hubs Site a Site B Site x special assay development ID Service center Oss Global CoE Site C ID Service center

4 Merck Microbiological Network Elkton, VA, USA West Point, PA, USA Brinny, IRL Carlow, IRL Swords, IRL Oss, NL Heist, BE Durham, NC, USA Menuma, JP Azcapotzalco, Mexico Xochimilco, Mexico Santo Amaro, BR Mirabel, FR Gisors, Caen, FR FR Singapore l

5 Worldwide network Labs to support ~ 24 Microlabs to support ~ 60 production sites Originally composed of Organon, Schering Plough and Merck facilities Complicated network to interact

6 Big Pharma 2016 World Class Supplier Shortest lead times Lowest costs Highest quality Lab automation will be one of the drivers to accomplish the WCS goal.

7 Current status Microbiology labs Paper based Hybrid system LIMS/paper Bold statement : LIMS is used as a sophisticated printer

8 Current status Microbology labs Manual testing Complicated paper flows Multiple reviewing steps and transfer steps from computer to paper and vica versa. Lean lab did not help to improve the situation

9 Sampletechnical flow Paper flow Current Flow of Samples and Data Customer s sample Sample 0.Label : All Manual Entries <0,5 D <2,5 D <0,5 D <3 D Request ID Request (external customer) Subculture sample Prep 0.Label Execute ID 2.Logbook Samples Reagents Run& steps Enter Result 3.Enter ID In Analysis software Raw Result 2.Logbook Analyzed Result QC QA Release result 5. Tech Verification Logbook +LIMS Report to Customer LIMS flow 1.Request (internal customer) ID number 4.Log Enter component Start date 4. Log Result 5. QA Approval Logbook +LIMS Print Final Report

10 The current logbook: high GMP value For a defined activity Tracking the samples*& reagents (release): Implement observations on subculture*, Tracking Sample Prep steps*, raw data Track interpreted result, * Independent technical verification* * By who and when v v v

11 High level data flow with ELN in Microbiology MicroSeq Reagents Additional Info No Result found Yes ELN glims Maldi-TOF Sample nr / Test number Sample 11

12 Oss Other sites Sample Identification Analysis Report Identification

13 Data Flow Primary laboratory processes Request registration sample App1 requester Check registration request Nugenesis App2 App3 technician Analyse ME mudule glims 1st line authorization 2nd technician 2nd line authorization (validation) authorisator Report

14 Challenge for us 24 microlabs Three continents Mix of practices Huge challenge for the microlabs Start simple glims is being introduced, very generic Lab modules needs to be implemented yet Tedious project (frustrating) Are there more drivers / shifts in paradigms helping us to get this done?

15 What would be the biggest driver for microlabs in the future? Introduction of Rapid Methods in the microlab Shift to small production batches, single use technology, modular facility FDA is focusing on data integrity at the labs in 2016.

16 Rapid methods in Microbiology Environmental monitoring Sterility Bioburden Endotoxin Mycoplasma Less visual examination >> shift to automated read outs.

Technologies for Rapid Micro Method Bioburden testing Milliflex Quantum Growth Direct MuScan Milliflex Rapid Growth-Based Time to result: 2.

5 day -3 days Barrcoding and interface with LIMS Not destructive, organism can be ID d Early Detection and Intervention is possible, system alerts real time Not - Growth-Based, direct detection

17 Technologies for Rapid Micro Method Bioburden testing Milliflex Quantum Growth Direct MuScan Milliflex Rapid Growth-Based Time to result: 2.5 to 3 days ; Staining increases method sensitivity Not destructive, organism can be ID d Can be viewed as Improved compendial Method Growth-Based High throughput, flexible loading Time to result ~2.5 day -3 days Barrcoding and interface with LIMS Not destructive, organism can be ID d Early Detection and Intervention is possible, system alerts real time Not - Growth-Based, direct detection method Time to Result -1 hour No incubation required Method sensitivity is higher since it detects viable non-culturable micro organisms Suitable for urgent problem solving Batching not possible Growth-Based Based on Adenosine Triphosphate (ATP) bioluminescence technology Time To Results is estimated at 2 days In principal technology allows no identification (cells are lysed) Automated Imaging Analysis Difficulty in validation, due to different incubation of different species of mo

18 Shift to small production batches, single use technology, modular facility The QC lab (off line) will disappear and will be replaced by in line (e.g direct air monitoring) on line (e.g autosamplers) at line testing (e.g portable instruments) Use of robots will dramatically increase.

Adaptive technologies have transformative potential to improve speed, flexibility, and reduce costs Conventional Form Fill Operations Flexible Form Fill Operations Key Enabling Technologies

19 Adaptive technologies have transformative potential to improve speed, flexibility, and reduce costs Conventional Form Fill Operations Flexible Form Fill Operations Key Enabling Technologies Single-Use Components Ready-to-Use Vials, Syringes Conventional: 1 syringe filler + 1 vial filler Formulation tank Adaptive Filling Adaptive vial / syringe filler Single-use bag and holder (replaces Stainless Steel tank infrastructure) Capital intensive Higher operational costs Large, rigid infrastructure Longer changeovers Requires high volumes to be cost effective ~30-40% reduction in capital costs ~20-25% lower OpEx Variabilizes costs Shorter changeovers Enables flexibility to accommodate product mix, smaller lots, and demand fluctuations 19

20 In een commentaar in dezelfde Science schrijft Rainer Martin van het Roche Innovation Center in Bazel dat zo n apparaat wonderen kan doen in rampgebieden en vluchtelingenkampen waar ziekten uitbreken. NCR 4 April Flexibele kast vervangt logge medicijnenfabriek Geneesmiddelen Een apparaat ter grootte van een koelkast maakt medicijnen op verzoek. Door onze redacteur Wim Köhler Amsterdam. Medicijnen hoeven niet langer in grote fabrieken te worden gemaakt. Het kan ook in een koelkastgroot apparaat. Dat laten onderzoekers van het Massachusetts Institute of Technology (MIT) zien in de Science van 1 april. De uitvinders produceerden vier uiteenlopende medicijnen, en zeggen er veel meer te kunnen maken de productie is in een paar uur om te schakelen. Onderzoeksleider Ping Zhang is inmiddels verhuisd naar een nabij het MIT gelegen researchlab van farmaceutisch bedrijf Novartis. Waarom is dit beter dan de bestaande medicijnproductie?

21 FDA is focusing on data integrity at the labs in 2016 and beyond 1. Visual examination of plates/ broths etc is under scrutiny 2. Data flow of paper/lims : >>>hybrid systems vulnerable for data integrity issues

22 The current logbook: high GMP value For a defined activity Tracking the samples*& reagents (release): Implement observations on subculture*, Tracking Sample Prep steps*, raw data Track interpreted result, * Independent technical verification* * By who and when v v v

23 Solution for those shifts in paradigms? Lab automation Automated analysis and read outs. Connected and integrated LIMS & Production IT systems Paperless

24 Timelines???? 10 years ago I entered the QC micro labs and was astonished we did not have integrated barcode systems for sample tracking. Current situation : Still the same. But.. Strong drivers are now coming up forcing the labs to be innovative.

25 Questions?

Risk-Based Monitoring

Risk-Based Monitoring Evolutions in monitoring approaches Voorkomen is beter dan genezen! Roelf Zondag 1 wat is Risk-Based Monitoring? en waarom doen we het? en doen we het al? en wat is lastig hieraan?